Jump to

Abstract

Introduction: This study assessed the risk of significant bleeding in patients on antiplatelet or anticoagulation therapy at time of device implantation.

Methods: We evaluated bleeding complications in all patients undergoing ICD or pacemaker implantation from August 2004 -August 2007. Aspirin or clopidogrel use was defined as use within 5 days of the procedure. A significant bleeding complication was defined as: need for pocket exploration or blood transfusion; hematoma requiring pressure dressing or change in anticoagulation therapy; or prolonged hospitalization.

Results: 1388 device implantation procedures met inclusion criteria and were used for analysis. Of these cases, 73 had bleeding complications (5.3%). Compared to controls not taking antiplatelet agents (n=255), the combination of aspirin and clopidogrel (n=139) significantly increased bleeding complications (7.2% vs. 1.6%; p=0.004). However, in patients taking aspirin alone (n=536), bleeding complications were comparable to those taking both aspirin and clopidogrel (7.2% vs. 4.3%; p=0.16), but higher than controls not on aspirin therapy (4.3% vs. 1.6%; p=0.05). The use of periprocedural heparin (enoxaparin or IV heparin) (n=154) markedly increased the risk of bleeding when compared to holding warfarin until the INR was normal (n=258) (14.3% vs. 4.7%; p<0.001) and to patients on no anticoagulation (14.3% vs.1.6%; p<0.0001). There was no statistical difference in bleeding complications between those continued on warfarin with an INR ≥ 1.5 (n=46) and patients who had warfarin withheld until the INR was normal (n=258) (6.5% vs. 4.7%; p=0.59).

Conclusions: Patients receiving dual antiplatelet therapy at the time of device implantation are at increased risk for significant bleeding complications. Likewise, patients receiving periprocedural heparin while warfarin is held are at significantly increased risk for bleeding complications. To reduce this risk, the need for continued antiplatelet agents, particularly dual therapy, or administration of heparin “bridging” should be carefully evaluated on a patient-by-patient basis.